Comparative Analysis of Quality Assessment Requirements for Gelatin Used in Drug Production (Review)
- 作者: Mironova M.1, Kovaleva E.1
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隶属关系:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- 期: 卷 50, 编号 12 (2017)
- 页面: 820-825
- 栏目: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244487
- DOI: https://doi.org/10.1007/s11094-017-1540-4
- ID: 244487
如何引用文章
详细
Gelatin is usually used as an excipient in drug preparations and more rarely as an active ingredient. Domestic quality standards regulating gelatin used in drug production were enacted over 20 years ago. A comparative analysis of quality requirements for gelatin in domestic and foreign pharmacopoeias seemed timely in order to justify national pharmacopoeial quality requirements for gelatin (quality parameters, analysis methods, norms) and to compose a pharmacopoeial monograph for gelatin in the RF State Pharmacopoeia.
作者简介
M. Mironova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
编辑信件的主要联系方式.
Email: SmirnovaM@expmed.ru
俄罗斯联邦, 8/2 Petrovskii Blvd., Moscow, 127051
E. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: SmirnovaM@expmed.ru
俄罗斯联邦, 8/2 Petrovskii Blvd., Moscow, 127051